Diet Intervention
Conditions
Keywords
Personalized
Brief summary
The proposed study has two primary objectives i.e. to examine how improvements in diet quality via a personalized dietary intervention 1) benefit cardiometabolic outcomes in young Black adults differentially compared to non-Hispanic White adults, and 2) improve carbohydrate and lipid metabolism in relation to the gut microbiome.
Detailed description
The study is an 8-wk randomized, controlled, parallel arm clinical trial in which participants (age: 18-35 years, BMI: 25-45 kg/m2, race/ethnicity: Black or White) will be block randomized to a personalized dietary intervention or to receive conventional dietary advice. Outcomes assessed will include metabolites involved in carbohydrate and lipid regulation, gut microbiome composition, and cardiometabolic biomarkers.
Interventions
OTHERPersonalized diet
Participants in this group will receive tailored nutrition counseling from a dietitian. To facilitate meeting these dietary goals, participants will be provided with nuts, fruits, and vegetables.
Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18-35 years of age * BMI: 25-45 kg/m2 * Black including those of Hispanic ethnicity, and Non-Hispanic White individuals * Willingness to consume nuts, fruits and vegetables * Willing to comply with study protocol * Consistent diet and activity patterns for 4 weeks * Weight stable (≤5 kg change over the last 3 months) (Self-reported) * Non-smoker \>1 year or more
Exclusion criteria
* Allergies to fruits, vegetables, and nuts provided in the study * Illicit drug use * Recent start of medications that affect metabolism or appetite * Antibiotics * Coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia requiring drug therapy * Uncontrolled hypertension and blood pressure ≥ 180/110 Diabetes * Gastrointestinal disease and/or bariatric surgery * HIV positivity * Pregnant or lactating individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glucoregulation | Change over 8 weeks | Fasting glucose concentrations |
| Change in diet quality | Change over 8 weeks | Healthy eating index score |
| Change in relative intensities of metabolites in blood | Change over 8 weeks | Measured by untargeted metabolomics mass spectrometry |
| Change in stool microbiome profiles | Change over 8 weeks | 16s rRNA sequencing |
| Change in endothelial function | Change over 8 weeks | Reactive hyperemia index |
| Matsuda index | Change over 8 weeks | Assessed via a 2-hour oral glucose tolerance test |
| Change in lipid profile | Change over 8 weeks | LDL, HDL, triglycerides, total cholesterol |
| Change in inflammatory markers | Change over 8 weeks | MCP-1,IL6, IL10, TNFa, hs-CRP, and fibrinogen |
| Change in blood pressure | Change over 8 weeks | Diastolic and systolic blood pressure |
| Change in insulinemic biomarker concentrations | Change over 8 weeks | Fasting insulin and C-peptide concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance rating of foods | Every 2 weeks over the 8 week intervention | 9-point food action rating scale |
| Body Mass | Every 2 weeks over the 8 week intervention | Body mass will be measured in kg |
| Body Composition | Every 2 weeks over the 8 week intervention | Fat mass, fat-free mass |
| Anthropometrics | Every 2 weeks over the 8 week intervention | Waist circumference, hip circumference |
| 24-hour appetite ratings | Every 4 weeks over the 8 week intervention | Subjective ratings using visual analog scales |
| Physical activity | Every 4 weeks over the 8 week intervention | Activity assessment using Actigraphs |
| Palatability rating of foods | Every 2 weeks over the 8 week intervention | Hedonic general labelled magnitude scale (gLMS) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Transcriptomics profiles | Baseline and at the end of the 8-week intervention | Untargeted transcriptomics |
| Food environment perceptions | Baseline and at the end of the 8-week intervention | Subjective and objective questionnaires |
| Memory | Change over 8 weeks | Word recall scores |
| Attention score | Change over 8 weeks | d2 test of attention |
Countries
United States
Outcome results
None listed